Summary:
Summary Statement of Deficiencies D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on review of laboratory policies and records, absence of records, and interview with General Supervisor (GS) 11/12/24, the laboratory failed to assess competency for the GS in 2022, 2023 and 2024, a period of approximately 3 years. Findings: Review of laboratory policy, "Johnston Pain Management Delegation of Duties and Responsibilities Policy - Clinical Laboratory Director Responsibilities for Moderate and High Complexity Testing," revealed, "...laboratory director (LD) is responsible for...including the employment of competent personnel...Assure personnel competency & training." Review of laboratory records for "General Supervisor Competency Assessment" revealed no documentation after initial training on 11/29 /2021. There was no documentation of GS competency assessments for 6 month and annual in 2022, and no documentation for annual in 2023 and 2024. During interview at approximately 11:45 a.m. GS stated competency assessments were completed but not recorded on GS competency assessment forms. GS called TS on speaker phone and confirmed GS competency was not recorded for 2022, 2023, and 2024. D6107 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(15) The laboratory director must specify, in writing, the responsibilities and duties of each consultant and each supervisor, as well as each person engaged in the performance of the preanalytic, analytic, and postanalytic phases of testing, that identifies which examinations and procedures each individual is authorized to perform, whether Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- supervision is required for specimen processing, test performance or result reporting and whether supervisory or director review is required prior to reporting patient test results. This STANDARD is not met as evidenced by: Based on review of personnel records for 2022, 2023, and 2024, and interview with General Supervisor (GS) 11/12/2024, the Laboratory Director (LD) failed to specify in writing the duties and responsibilities for the Clinical Consultant (CC), Technical Supervisor (TS), GS, and Testing Personnel (TP) involved with the daily operation of the laboratory and testing process. Findings: Review of personnel records revealed the absence of a job description for the following positions: 1. CC 2. TS 3. GS 4. TP During interview at approximately 12:05 p.m., GS stated she was not sure of the position descriptions. During the exit conference, the GS confirmed position descriptions were not available for CC, TS, GS, and TP. -- 2 of 2 --